FIASCO - Never Events in Cardiac Surgery

The main reason why cardiac surgeons were the first to publish meaningful surgical outcomes is the ability for them to risk stratify each individual patient about to undergo heart surgery.  In other words, it is possible to state the risk of that particular patient dying or even more usefully to state what the predicted death rate for a group of patients is. This can than be compared to the actual death or mortality rate. Using this data, it is possible therefore to correct for the fact that certain surgeons operate on higher risk patients than others. In In this novel study entitled FIASCO, Nashef et al from Papworth Hospital examined the deaths of patients who had very low risk scores - i.e. they were not expected to die. As expected the mortality rate was very low and the individual circumstances surrounding each death were different from those discovered when a similar analysis was made several years ago - evidence that the team was learning.
This exercise is immensely useful to me in my cardiac surgical practice. In my opinion every death should reviewed at an M&M (Morbidity and Mortality) meeting. But what this study has added is that every death of a 'low risk' patient (and low risk is easily defined in cardiac surgery) should be classed as a never event and investigated fully with all the resources an institute has at its disposal. 

See One, Do One, teach one - Measuring the Learning Curve.

One of the possible victims of public reporting of surgical outcomes of individual surgeons is Surgical Innovation.  When a surgeon is under scrutiny, he dare not innovate lest he fails. Learning a new technique means that initially the operative outcome will not be as good as when the surgery is performed by a surgeon already experienced in this new technique. But if the new technique carries potential advantages, it must be disseminated. So how is this quandary solved? How does a surgeon get over this so called learning curve? This paper by German surgeons on the training of minimally invasive mitral heart valve surgery turns the measuring of the learning curve into a quasi science. There are recognised ways of getting over the learning curve without harming or disadvantaging  patients - using simulation and operating with experienced 'buddies' to start with (so called buddy system) are 2 commonly used. Measuring the learning curve and knowing when a surgeon is ready to fly solo is therefore of crucial importance - which is why this paper from Leipzig is worthy of mention. 

The Genius of Da Vinci

Leonardo da Vinci was right all along, new medical scans show - Telegraph
The Queen owns many of Leonardo da Vinci's quite extraordinary anatomical sketches. Although these are accurate and beautiful, they cannot be seen as evidence of his predictive powers - after all an MRI of a hand today just reveals what anyone could expose by dissection of a body - an activity that predated Leonardo. What is even more amazing about Leonardo da Vinci are (amongst other things) his observations on physiology and blood flow. The illustrations show one of his diagrams of blood flow within the sinuses of Valsalva, the bulges of the aorta at the point it exits from the heart, together with proof by MRI that what he described in his drawing I.e the swirling of blood in this region  is actually what happens. Should MRI not be referred to as the LTM - Leonardo Truth Machine ?

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The Perfect Human Valve Substitute ?

The quest for the perfect heart valve substitute goes on. This article in recent edition of the Circulation journal shows how little has changed in the 50 years we have been implanting prostheses to replace diseased human aortic valves. Patients who have mechanical heart valves still require anticoagulants and are at greater risk of strokes or anticoagulant related haemorrhages. The new anticoagulants have not and will not change that reality. Patients who receive biological valves are at higher risk of requiring reoperations due to degeneration of the prosthesis. The cut off age for the use of mechanical prosthesis used to be 70 years. (Below 70 mechanical, above biological). Over the past decade, it has drifted downwards first to 65 then to 60. Although the rate of bioprosthetic degeneration does slow with age (possibly related to calcium turnover) the main determinant of whether degenerative changes become clinically significant is years of life with the prosthesis in situ I.e. longevity or prognosis. As life span of both women and men has increased rapidly over the past 20 years, the cut off age should in my opinion, be going up and not down. This downward drift in cut off age has not occurred because of new evidence or because of dramatic new developments in the design or manufacture of biological valve prosthesis. What has driven this change is marketing and the advent of TAVI (Transcutaneous Aortic Valve Implantation) or valve on a catheter. This device ( which is essentially a biological prosthesis that is collapsed around a catheter ) can be used to treat a stenosed native aortic valve or a degenerating surgically implanted prosthesis without the need for open surgery. A TAVI device inside a degenerating biological prosthesis is a very imperfect solution for many people who might still have 10 or more years of like ahead of them. What is needed and what has not yet been invented is a biological valve that does not degenerate over time or a mechanical valve that is completely non-thrombogenic. The advent of stem cell technology and the emerging concept of using acellular valves that get seeded by autologous cells suggest that the former I.e. a perfect biological valve is more likely to be invented than the latter. I won't however be holding my breath.

 

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NHS England and Mitraclip - Room for Improvement

MitraClip passes FDA hurdle | theheart.org
Mitraclip is a device that can be used to treat a leaking mitral valve, which is one of the valves in the heart..  The main advantage of this device is that it  can be inserted percutaneously without the need for open surgery. The gold standard treatment for mitral regurgitation is surgery. However not all patients are suitable or fit for open surgery. Mitral regurgitation is also an epiphenomenon of heart failure and when present is associated with repeated need for hospitalisation. This type of mitral regurgitation is very rarely dealt with surgically.  Use of the mitraclip therefore has the potential to decrease many admissions to hospital due to heart failure.  More than 4000 of these devices have been inserted into patients in Europe since 2008 when the CE mark was awarded. The American FDA, who traditionally are very conservative when it comes to approving devices has finally given a stamp of approval through one of its expert advisory panels. These panels consist of cardiologists and cardiac surgeons who are recognised experts in the field of mitral valve disease and related heart failure.  The proceedings of these panels are open and transparent. 
In the UK, there is no equivalent of the FDA. Devices are approved as being safe with a CE mark granted by the European Union. There is no requirement for them to be effective. As one can imagine, the bar for CE marking is set pretty low. Mitraclip has had a CE mark for several years.  The NHS commissioning board or as it is now known NHS England are responsible for commissioning of specialised procedures and devices.   In recent weeks it has published guidelines on the commissioning of specialised procedures. It has decided that the NHS will not routinely commission Mitraclip. It will however  'Commission through Evaluation". This process is described on NHS England's website  - ‘Commissioning through Evaluation’ enables treatments or procedures to be commissioned initially on a limited basis whilst further evaluation is carried out to determine whether a substantive commissioning policy should be developed for future use'.
I am not sure that this position NHS England have decided to adopt is logical. It certainly is vague. There is no doubt that the Mitraclip reduces mitral regurgitation in a safe fashion and there is no doubt that it does so in a less traumatic & less invasive fashion when compared to surgery. That surely is the only evidence one requires before commissioning. The decision as to whether the patient is treated percutaneously, surgically or medically should be taken by the patient's physician or Heart Team. It is this decision that will be determined by emerging evidence.

The Difficult Problem that is Aortic Dissection.

There is no other cardiothoracic procedure that is as challenging as the management of a patient with type A aortic dissection.
Untreated, the immediate mortality rate is 1% per hour.   The surgery to repair a type A dissection is extremely challenging, patients are very sick, and coagulopathic and the dissected vascular tissues are incredibly friable and difficult to work with. To make matters worse, the average on call surgeon dealing the majority of these cases will only operate on a very small number of aortovascular cases per year.  The operative mortality in most countries of the world for this procedure is around 25-30%.
I have come across this excellent video presented recently by the American Society of Thoracic Surgeons on some of the very difficult issues surrounding the operative management of these patients.
It is worth a share!

Off Pump Coronary Surgery (OPCAB) and the Evolution of My Pragmatism!

I have been observing and then performing coronary artery surgery since 1988. It was in 1992 when I first heard of Subramanian's first published accounts of LIMA to LAD coronary bypass done off pump i.e. without the aid of a heart lung machine.

The Emotion of Transplant Surgery

I watched this episode of Horizon recently on BBC iplayer - it featured 40 years of coverage of progress in transplant science and surgery on the BBC. The programme brought back so many memories and emotions about transplant surgery related events that have occurred during my training as well as the great people who I have had the privilege to work with and/or meet on the way - people like the late great Norman Shumway, Michael Debakey, Joel Cooper, Roy Calne, Terence English, John Wallwork, Randy Morris and David White. It also made me think a great deal of how so much has changed in medicine - not only the medical and surgical progress that has occurred over the past 30 to 40 years but also the bigger changes that have influenced HOW we practice medicine i.e the advent of MDTs, guidelines and evidenced based medicine and our relationship with patients and the effect of the world's fiscal situation which whether we like it or not will be a major determinant of progress over the next 30 years.
There is no doubt that doctors (surgeons usually) did things that would today lead them to be struck off and imprisoned (in the UK at least ). Will this mean in the future progress will be slower or just different?
The scene featuring the girl with cystic fibrosis brought a lump to my throat - it reminded me of a patient who I looked after and who featured on one of the programmes in this special called Knife to the Heart.
A final point I would like to make is that this work is a Clinical Ethical minefield e.g. shortening the lifespan of a patient with immunosuppressive drugs (including steroids) for cosmetic reasons (hand/face transplant) or performing surgery (living related lung or liver transplant) that has a potential 300% mortality are issues I would have difficulty dealing with today.

Is this A Dangerous Precedent ?

I really cannot tell whether suspending paediatric cardiac operations at Leeds General Infirmary was the right or wrong thing to do - I just do not have the facts to make a judgement .
What I can tell for sure is that Sirs Bruce Keogh and Roger Boyle, both of whom I know and greatly respect, have set a precedent on how to deal with adverse surgical outcomes.
From April 1st,  Bruce Keogh promised that outcomes of a number of surgical procedures performed in England will be published. There will be surgeons and units with mortality rates that are double the national average.
Are we therefore going to see a whole host of closures and investigations started before the month of April is up?

Surgical Outcomes Reporting - why we are Missing the Point.

JAMA Network | JAMA Surgery | Failure to Rescue Patients After Reintervention in Gastroesophageal Cancer Surgery in EnglandFailure to Rescue in Gastroesophageal Cancer

Although cardiac surgery is very different from other surgical specialties (and cardiac surgeons seem alien to many!) there is a lot I, as a cardiac surgeon can learn from more conventional surgical specialties. I often browse through thoracic and general surgical journals. I even enjoy reading the Annals of my College - the Royal College of Surgeons of England. I stop short however of reading orthopaedic rags - I have never had ANY professional affinity with that lot - no offence boys/odd female!!
I digress. This paper in JAMA surgery (the journal formerly known as Archives of Surgery!) is fascinating. It confirms what has been previously publicized in yet another excellent piece by surgeon racconteur, Atul Gawande in this piece in the New Yorker. Gawande describes the findings of a research study from University of Michigan that demonstrated that a major reason for variation in mortality rates after surgical procedures between different hospitals was not the incidence of things going wrong or morbid events but the ability of the institution to rescue patients once things went pear shaped. This study from England looking at events occurring after (o)esophagectomy replicates these findings. If one thinks about the incidence of morbid events or death after surgery, these findings are perhaps not so surprising. We know from many studies in different surgical specialties that a major contributor to the spread of incidences of complications are the patients themselves - advanced age, co-morbid conditions etc.   But how much does the surgeon's ability contribute to variation in mortality between centres after surgery? In any one developed country, the vast majority of surgeons are trained to the same standards -standards which  do not vary greatly between schools of surgery. In addition graduates from each school end up working all over the country. Both these factors contribute to the uniformity and narrow standard deviations of surgical ability in any one country.  This  paper is therefore significant on a number of levels - it confirms the fact on both sides of the Atlantic that variation between surgical outcomes are due predominantly to systemic institutional factors. It is also important because Bruce Keogh, medical director of the National health service in England and ex cardiac surgeon has decided that many surgical specialties should follow the Cardiac Surgeons and publicly report individual surgeons' outcomes. There is a moral case for this - patients are entitled to know what the clinical outcomes of the surgeon who is about to operate on them, are. This paper above, other studies and common sense suggest however that Bruce Keogh and many of the colleges and professional societies who support this stance, are missing the point.

Cardiac Surgeons and the Management of Stroke

Atrial fibrillation causes 15% of strokes in the West and the UK.  There is evidence to suggest occlusion of the left atrial appendage percutaneously with a device called the Watchman is as effective as warfarin in decreasing the incidence of stroke.
Does the same apply to exclusion of the appendage by surgical/open means? Surgical exclusion can be done inexpensively using prolene sutures or expensively using devices such as the Atriclip or Tigerpaw. Such exclusion is usually performed concomitantly with other cardiac surgical procedures such as CABG (coronary artery bypass grafting) or mitral valve surgery.  It is a procedure that is essentially risk free and one that may have life changing benefits for the patients. One wonders how often the appendage is closed off in patients with AF undergoing cardiac surgical procedures?
The fact that percutaneous closure of the appendage is effective at decreasing stroke does not necessarily mean that surgical closure will have the same effect - after all surgery itself has procoagulant effects that may have a negative influence. Trial evidence is needed and if surgical closure is effective at decreasing the incidence of stroke, than this procedure, concomitant or even standalone may very well become more common.

Should we All have a Robot?

JAMA Network | JAMA | Comparative Effectiveness Research on Robotic SurgeryComparative Effectiveness and Robotic Surgery
An interesting leader in JAMA this week about the true usefulness and cost effectiveness of robotic surgery.

Pulseless and Alive!

In recent years, progress towards the development of the perfect artificial heart to replace a failing one, has been rapid, outpacing progress towards the development of a Xenogeneic transplanted alternative or construction ex vivo of a new organ using stem cells.
A combination of advances in engineering, in pharmacology to develop new anticoagulants, and in battery technology has brought us to this place.
One of the features of these new machines has been continuous flow and the abandonment of pulsatility as a goal for assist devices. Contrary to what we have been led to believe over the past century, circulation does not have to be pulsatile to support human tissue.
This is a great short film full of typical Texan chutzpah recounting the very human story of how one man was brought back to life and how in the process, lost his pulse!

What is Quality in Surgery - Sir Bruce Speaks.

The European Association of Cardiothoracic Surgeons has released a number of videoed discussions that took place at their annual meeting in Barcelona in October 2012.

How do you train a Surgeon?

The European Association of Cardiothoracic Surgeons has released a number of videoed discussions that took place at their annual meeting in Barcelona in October 2012.

What you can do with Clinical Data - the Gospel according to Tim Kelsey

STS Survival Calculator
This calculator is found on the website of the Society of Thoracic Surgeons, one of the 2 big professional Cardiothoracic Societies in the USA. With a few clinical variables, you can calculate the survival potential of any individual patient. It demonstrates the incredible things you can do with comprehensive clinical data. Tim Kelsey is the first National Director for Patients and Information in the National Health Service and sits on the NHS Commissioning Board. He is championing the comprehensive use of digital clinical data for the benefit of patients. 
In this video he talks about the liquidity (great term) of data and why and how the use of clinical data, which is already there in the ether/cloud will shape how the new NHS will develop. 

Tim Kelsey: A patient-centred NHS from Nuffield Trust on Vimeo.

How to link 5 stories to 1 Narrative or Why Cardiac Surgeons are not doing the right operation.

Reports of the death of the Coronary Artery Bypass Grafting Operation (CABG) are plentiful and exaggerated.

Surgical Self Flagellation

Sir Bruce Keogh is  in the news today because of his appearance on tonight's edition of ' The Report'  - a topical programme on Radio 4 which today deals with Surgeons under Scrutiny. 

Death of a Pioneer and the British Connection

Today, the death of Joseph Murray was announced. He was 93 years of age. He was hugely influential in the evolution of solid organ transplantation and during my years in transplantation and transplantation research, his name and work cropped up frequently. The fact that he won the Nobel Prize reflected his contribution.
There is a strong British connection with this man. Sir Roy Calne, British surgeon, transplant pioneer, academic, artist etc worked with Joe Murray in Boston in the early 1950s. His work in Murray's lab  was the first to establish the fact that organ (kidney) rejection in dogs could be controlled by drugs - the birth of the immunosuppressive drug. The first drug was  6 Mercaptopurine, later changed to Azothioprine - still used today as an immunosuppressant.  In Cambridge, Roy Calne went on to be involved in the evolution of cyclosporine and with Randall Morris and Norman Shumway at Stanford, rapamycin or sirolimus. I was a cardiopulmonary transplant fellow in Cambridge in the early 1990s & I worked with Randy Morris and Norm Shumway in the lab at Stanford in the mid 1990s - hence the connection and interest! 

Gertrude Elion at Harvard Medical School with Dr. Roy Calne, Dr. George Hitchings, Dr. Donald Searle, Dr. Hager, and Dr. Joseph, Murray, and the dogs Tweedledum, Tweedledee, Titus, and Lollipop (recipient of the first successful foreign kidney transplant)

(courtesy of Jewish Women's Archive)

the Best of European Society of Cardiology Annual Meeting 2012

An excellent summary programme of the recent annual meeting of the  European Society of Cardiology meeting in Munich Germany where many landmark cardiac trials were presented.